İntraoperative Awareness Under General Anesthesia

NCT04697732 | Unknown

• 1 other identifier: KA12/154
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative awareness which means the recall of experiences recorded in patients' memories during general anesthesia in the postoperative period is an important issue in anesthesia practice. The aims of this study are to investigate the incidence and causes of awareness during general anesthesia, incidence of dreaming during anesthesia, intra-operative experiences of patients who report awareness, the risk factors that may be associated with awareness, to analyze the frequency of posttraumatic stress disorder in cases with awareness and possible awareness, the risk factors that may be associated with PTSD in Turkish adults. Adult patients will be evaluated 4 time following emergence (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone. Each interview will be conducted using the same structured interview (Brice Interview). Descriptive statistics will be used to determine the incidence of awareness. χ2 test will be used for comparison between groups. Logistic regression will be used to determine the risk factors associated with awareness and PTSD. We believe that this study will contribute to the prevention of the problem by determining the real frequency and causes of intraoperative awareness under general anesthesia, determining the experiences and results of patients, and analyzing the associated risk factors.

Conditions

To Investigate the Incidence and Causes of Awareness During General Anesthesia; To Investigate the of Dreaming During Anesthesia; To Investigate the Intra-operative Experiences of Patients Who Report Awareness; To Investigate the Risk Factors That May be Associated With Awareness; To Analyze the Frequency of Posttraumatic Stress Disorder in Cases With Awareness and Possible Awareness; To Investigate the Risk Factors That May be Associated With Posttraumatic Stress Disorder

Keywords

intraoperative awareness; general anesthesia; dreaming; incidence

Outcome Measures

Primary Outcomes (4)

• Modified Brice interview

  This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

  One hour after emergence

• Modified Brice interview

  This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

  Twenty four hour after emergence

• Modified Brice interview

  This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

  One week after emergence

• Modified Brice interview

  This interview consists of 5 questions. Patients will be evaluated at 4 different timepoints following emergence. First interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

  One month after emergence.

Study Arms (1)

Adult patients age above 18 years

ASA I-IV adult patients over 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively, who can give informed consent, have no known psychological or psychiatric problems, and who are suitable for postoperative follow-up.

Other: General anesthesia

Interventions

General anesthesia OTHER

Following emergence from general anesthesia, patients will be evaluated at 4 different timepoints; (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.

Also known as: Modified Brice Interview

Adult patients age above 18 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ASA I-IV adult patients above 18 years of age who will receive general anesthesia and are scheduled to be extubated postoperatively,

You may qualify if:

• ASA I-IV adult patients who will receive general anesthesia and are scheduled to be extubated postoperatively,

You may not qualify if:

• ASA V patients
• Patients below 18 years of age,
• Patient who can not give informed consent,
• Patients who have known psychological or psychiatric problems,
• Patients who are not suitable for postoperative follow-up

Sponsors & Collaborators

• Baskent University Ankara Hospital: lead

Study Sites (1)

Baskent University

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (27)

• Sebel PS, Bowdle TA, Ghoneim MM, Rampil IJ, Padilla RE, Gan TJ, Domino KB. The incidence of awareness during anesthesia: a multicenter United States study. Anesth Analg. 2004 Sep;99(3):833-839. doi: 10.1213/01.ANE.0000130261.90896.6C.

  PMID: 15333419 BACKGROUND

• Sandin RH, Enlund G, Samuelsson P, Lennmarken C. Awareness during anaesthesia: a prospective case study. Lancet. 2000 Feb 26;355(9205):707-11. doi: 10.1016/S0140-6736(99)11010-9.

  PMID: 10703802 BACKGROUND

• Moerman N, Bonke B, Oosting J. Awareness and recall during general anesthesia. Facts and feelings. Anesthesiology. 1993 Sep;79(3):454-64. doi: 10.1097/00000542-199309000-00007.

  PMID: 8363069 BACKGROUND

• Ghoneim M. The trauma of awareness: history, clinical features, risk factors, and cost. Anesth Analg. 2010 Mar 1;110(3):666-7. doi: 10.1213/ANE.0b013e3181cb5dfa. No abstract available.

  PMID: 20185645 BACKGROUND

• Lennmarken C, Bildfors K, Enlund G, Samuelsson P, Sandin R. Victims of awareness. Acta Anaesthesiol Scand. 2002 Mar;46(3):229-31. doi: 10.1034/j.1399-6576.2002.t01-1-460301.x.

  PMID: 11939910 BACKGROUND

• Mashour GA. Posttraumatic stress disorder after intraoperative awareness and high-risk surgery. Anesth Analg. 2010 Mar 1;110(3):668-70. doi: 10.1213/ANE.0b013e3181c35926. No abstract available.

  PMID: 20185646 BACKGROUND

• Bischoff P, Rundshagen I. Awareness under general anesthesia. Dtsch Arztebl Int. 2011 Jan;108(1-2):1-7. doi: 10.3238/arztebl.2011.0001. Epub 2011 Jan 10.

  PMID: 21285993 BACKGROUND

• Errando CL, Perez-Caballero P, Gelb AW, Sigl JC. Methodology, human factors, and incidence of intraoperative awareness. Acta Anaesthesiol Scand. 2010 Jul;54(6):781-3. doi: 10.1111/j.1399-6576.2010.02216.x. No abstract available.

  PMID: 20618162 BACKGROUND

• Enlund M, Hassan HG. Intraoperative awareness: detected by the structured Brice interview? Acta Anaesthesiol Scand. 2002 Apr;46(4):345-9. doi: 10.1034/j.1399-6576.2002.460402.x.

  PMID: 11952430 BACKGROUND

• Kotsovolis G, Komninos G. Awareness during anesthesia: how sure can we be that the patient is sleeping indeed? Hippokratia. 2009 Apr;13(2):83-9.

  PMID: 19561776 BACKGROUND

• American Society of Anesthesiologists Task Force on Intraoperative Awareness. Practice advisory for intraoperative awareness and brain function monitoring: a report by the american society of anesthesiologists task force on intraoperative awareness. Anesthesiology. 2006 Apr;104(4):847-64. doi: 10.1097/00000542-200604000-00031. No abstract available.

  PMID: 16571982 BACKGROUND

• WINTERBOTTOM EH. Insufficient anaesthesia. Br Med J. 1950 Jan 28;1(4647):247. doi: 10.1136/bmj.1.4647.247-c. No abstract available.

  PMID: 15404998 BACKGROUND

• Sandlin D. A closer look at bispectral index monitoring. J Perianesth Nurs. 2001 Dec;16(6):420-2. doi: 10.1053/jpan.2001.28748.

  PMID: 11740782 BACKGROUND

• Ishizawa Y. Mechanisms of anesthetic actions and the brain. J Anesth. 2007;21(2):187-99. doi: 10.1007/s00540-006-0482-x. Epub 2007 May 30.

  PMID: 17458649 BACKGROUND

• Domino KB, Posner KL, Caplan RA, Cheney FW. Awareness during anesthesia: a closed claims analysis. Anesthesiology. 1999 Apr;90(4):1053-61. doi: 10.1097/00000542-199904000-00019.

  PMID: 10201677 BACKGROUND

• Xu L, Wu AS, Yue Y. The incidence of intra-operative awareness during general anesthesia in China: a multi-center observational study. Acta Anaesthesiol Scand. 2009 Aug;53(7):873-82. doi: 10.1111/j.1399-6576.2009.02016.x. Epub 2009 Jun 3.

  PMID: 19496761 BACKGROUND

• Errando CL, Sigl JC, Robles M, Calabuig E, Garcia J, Arocas F, Higueras R, Del Rosario E, Lopez D, Peiro CM, Soriano JL, Chaves S, Gil F, Garcia-Aguado R. Awareness with recall during general anaesthesia: a prospective observational evaluation of 4001 patients. Br J Anaesth. 2008 Aug;101(2):178-85. doi: 10.1093/bja/aen144. Epub 2008 May 30.

  PMID: 18515816 BACKGROUND

• Pollard RJ, Coyle JP, Gilbert RL, Beck JE. Intraoperative awareness in a regional medical system: a review of 3 years' data. Anesthesiology. 2007 Feb;106(2):269-74. doi: 10.1097/00000542-200702000-00014.

  PMID: 17264720 BACKGROUND

• Myles PS, Leslie K, McNeil J, Forbes A, Chan MT. Bispectral index monitoring to prevent awareness during anaesthesia: the B-Aware randomised controlled trial. Lancet. 2004 May 29;363(9423):1757-63. doi: 10.1016/S0140-6736(04)16300-9.

  PMID: 15172773 BACKGROUND

• Ekman A, Lindholm ML, Lennmarken C, Sandin R. Reduction in the incidence of awareness using BIS monitoring. Acta Anaesthesiol Scand. 2004 Jan;48(1):20-6. doi: 10.1111/j.1399-6576.2004.00260.x.

  PMID: 14674969 BACKGROUND

• Wennervirta J, Ranta SO, Hynynen M. Awareness and recall in outpatient anesthesia. Anesth Analg. 2002 Jul;95(1):72-7, table of contents. doi: 10.1097/00000539-200207000-00013.

  PMID: 12088946 BACKGROUND

• Ranta SO, Laurila R, Saario J, Ali-Melkkila T, Hynynen M. Awareness with recall during general anesthesia: incidence and risk factors. Anesth Analg. 1998 May;86(5):1084-9. doi: 10.1097/00000539-199805000-00035.

  PMID: 9585303 BACKGROUND

• Nordstrom O, Engstrom AM, Persson S, Sandin R. Incidence of awareness in total i.v. anaesthesia based on propofol, alfentanil and neuromuscular blockade. Acta Anaesthesiol Scand. 1997 Sep;41(8):978-84. doi: 10.1111/j.1399-6576.1997.tb04823.x.

  PMID: 9311394 BACKGROUND

• Schwender D, Kunze-Kronawitter H, Dietrich P, Klasing S, Forst H, Madler C. Conscious awareness during general anaesthesia: patients' perceptions, emotions, cognition and reactions. Br J Anaesth. 1998 Feb;80(2):133-9. doi: 10.1093/bja/80.2.133.

  PMID: 9602573 BACKGROUND

• Osterman JE, van der Kolk BA. Awareness during anesthesia and posttraumatic stress disorder. Gen Hosp Psychiatry. 1998 Sep;20(5):274-81. doi: 10.1016/s0163-8343(98)00035-8.

  PMID: 9788027 BACKGROUND

• Forman S. Awareness during general anesthesia: Concepts and controversies. Periop Med and Pain 2006; 25: 211-218

  BACKGROUND

• Leslie K, Davidson AJ. Awareness during anesthesia: a problem without solutions? Minerva Anestesiol. 2010 Aug;76(8):624-8.

  PMID: 20661203 BACKGROUND

MeSH Terms

Conditions

Intraoperative Awareness

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Intraoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Bahattin Tuncali

  Baskent University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahattin Tuncali

CONTACT

+90 232 2411000; tuncali.bahattin@gmail.com

Yonca Ozvardar Pekcan

CONTACT

+90 232 2411000; yncapek@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 6, 2021
• Study Start: July 17, 2012
• Primary Completion: July 17, 2022
• Study Completion: December 31, 2022
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

TU (1)